ATLANTA — For hundreds of thousands of people battling Alzheimer's, the Food and Drug Administration granted full approval and endorsed the IV drug, Leqembi, on Thursday.
It's the first medicine proven to slow Alzheimer's progression.
The approval now triggers a change for Medicare and Medicaid, which could make it cheaper for a lot of people.
Medicare administrator, Chiquita Brooks-LaSure, has made clear the program will immediately begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements.
In order to get Leqembi, Medicare recipients must be enrolled in a federal registry to track the drug's real-world safety and effectiveness. The information will help advance “knowledge of how these drugs can potentially help people,” Medicare officials said.
Hospitals and medical clinics have also cautioned that it may take time to get people started on the drug.
Doctors need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.
Meanwhile, many studies are still being conducted on the cognitive impact of Alzheimer's disease.
In Atlanta, Emory University is conducting several Alzheimer's studies. The university is currently enrolling participants for the AHEAD study. However, the study does not include the Lequembi drug.
The four-year study is for participants, who are 55 to 80 years old, and are at risk of developing symptoms of Alzheimer's disease as they get older. The study's main objective is to target the earliest changes in the brain due to Alzheimer's, according to the AHEAD study's website.
Click here for more information on Emory University's Alzheimer's research and enrollment in its clinical trials. You can also find additional details about the AHEAD study online here.